Which predilatation balloons provide the best lesion preparation prior to use of drug coated balloons in de-novo lesions? Results from the PREPARE study.

BACKGROUND: There is a lack of data on the clinical outcomes following the use of different strategies for lesion preparation prior to the use of drug-coated balloons (DCB). In this study, we have explored the clinical outcomes between different types of predilatation balloons: semi-compliant (SB), non-compliant (NB) and scoring balloons (ScB) used when preparing de-novo lesions prior to the use of DCB. METHODS: We retrospectively evaluated all patients who underwent treatment with DCB for de-novo lesions between 2011-2019 at 4 high-volume European centres. The measured study endpoints were cardiac-death, TV-MI, TLR and MACE. RESULTS: During the study period, 553 patients were treated with DCB for de-novo lesions, 327 with SB only, 172 with NB and 54 with ScB. There were some differences in the procedural characteristics between the 3 groups. Predilatation balloons were significantly larger in the ScB, and NB groups as compared to the SB (2.7 mm and 2.6 mm vs. 2.3 mm; P<0.001). The reference vessel diameter was significantly larger in the NB group as compared to the ScB and SB (2.6 mm vs. 2.2 mm and 2.3 mm; P<0.001). During the median follow-up duration of 547-days, there were no differences in the hard-clinical endpoints, however, TLR was significantly higher in the ScB as compared to SB and NB group (11% vs. 3.4% and 4.7%; P=0.02). CONCLUSIONS: The PREPARE study results do not suggest routine use of ScB prior to DCB in de-novo lesions.

Drug-coated balloon for the management of coronary chronic total occlusions.

There is a higher rate of successful recanalization of patients with coronary chronic total occlusions, nevertheless, the rate of patients referred for revascularization remains low. In addition, there is a greater need to improve long-term outcomes of chronic total occlusions after percutaneous coronary intervention, and although the implantation of new-generation drug-eluting stents has been optimized with coronary imaging guidance, the rate of stenting failure remains a major issue and long-term vessel patency could be improved. We reviewed clinical data regarding the benefit of treating chronic total occlusions and the use of drug-coated balloons as an alternative therapeutic modality in this setting. Although clinical data is limited, the initial evidence and the daily clinical practice point towards a synergistic hybrid treatment strategy based on the combination of drug-coated balloons plus drug-eluting stents, reducing the total stent length and maintaining the scaffolding properties of stents where it is mandatory. Additionally, drug-coated balloons allow natural enlargement of the open vessel after percutaneous coronary intervention (PCI), which is a major limitation of stents in chronic total occlusion (CTO).

DCBs as an adjuvant tool to DES for very complex coronary lesions.

Drug eluting stents (DES) have revolutionised interventional cardiology and currently represent the standard for percutaneous coronary interventions (PCI). However, due to several limitations, new strategies are required, especially in very complex lesions. Drug-coated balloons (DCB) offer an attractive therapeutic alternative, and have already obtained a Class I recommendation for the treatment of in stent restenosis (ISR) with Level A of evidence. Moreover, the role of DCB has been tested in several other settings, such as de novo large vessel disease, multivessel disease or very complex lesions, with promising results regarding safety and effectiveness. In this context, a hybrid strategy consisting in the use of a DES and DCB with the aim of reducing the amount of metal implanted and minimising the risk of ISR and stent thrombosis could become the solution for very complex lesions. Several important studies already demonstrated very good angiographic results in terms of late lumen loss and restenosis for this approach in bifurcation lesions. Moreover, for long diffuse coronary disease similar rates of MACE, TVR, and TLR at 2-year follow-up in comparison to a DES-alone strategy were found. What is more, the use of this strategy in high-bleeding risk patients could safely permit the practitioners to reduce the DAPT duration, as data is suggesting. As our daily practice already strongly incorporated this strategy and with more data expected from important trials, it is our strong believe that the hybrid approach can become a standard treatment choice in the near future.

Long-term follow-up after sirolimus-coated balloon use for coronary artery disease. Final results of the Nanolutè study.

OBJECTIVES: To test the long-term efficacy of a sirolimus-coated balloon (SCB). BACKGROUND: Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data. METHODS: All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI). RESULTS: A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%). CONCLUSION: The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.